The Functional Quality Specialist I will ensure high-quality service delivery to internal and external clients while adhering to safety regulations, including the Health and Safety at Work Act 1974, COSHH Regulations 1989, and EC Directives 1992/3. The role involves quality review, compliance monitoring, and process improvement in pharmacovigilance and safety reporting.

Key Responsibilities

• Conduct quality reviews of assigned cases and compile quality metrics.
• Assist in client quality reviews and Corrective and Preventive Actions (CAPA).
• Review safety reports for regulatory submissions (e.g., PSURs, PADERs, Clinical Study Reports).
• Manage expedited adverse event reports, product complaints, and medical information queries.
• Support audit readiness and regulatory inspections.
• Develop Quality Management Plans and track training schedules for new hires.
• Analyze data to identify process improvements and ensure compliance with GCP, GVP, and ICH guidelines.
• Handle medical information queries via phone, email, or fax.
• Guide safety associates in call intake and documentation.

Qualifications & Experience

Minimum Required:

• Education: Bachelor’s/Master’s/PhD in Medicine, Pharmacy, Life Sciences, Nursing, or related fields.
• Experience: 2+ years in pharmaceutical/biotech/CRO industry, with exposure to Pharmacovigilance, Safety Writing, or Quality Review.
• Knowledge:
  • Medical & drug terminology
  • GCP, GVP, ICH Guidelines
  • EU & FDA regulatory requirements
• Technical Skills: Proficiency in Microsoft Office.

Preferred Qualifications:

• Experience in quality metrics & trend analysis.
• Knowledge of Medical Device Reporting (MDR).
• Experience in CAPA management.

Work Environment

• Hybrid/Remote options available.
• 10% travel may be required.

How to Apply

Application Link